Initiation
of the First Safety Trial in Africa of an Antiretroviral-Containing
Vaginal Ring Designed to Prevent HIV/AIDS
Study in Southern and East Africa evaluates safety and acceptability
of combining proven, long-acting women's health technology with
antiretroviral drugs to prevent HIV
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Washington,
DC -- June 8, 2010 -- The nonprofit International Partnership
for Microbicides (IPM) today announced the initiation of the
first trial among women in Africa testing a vaginal ring containing
an antiretroviral drug (ARV) that could one day be used to prevent
HIV transmission during sex. The clinical trial, known as IPM
015, tests the safety and acceptability of an innovative approach
that adapts a successful technology from the reproductive health
field to give women around the world a tool to protect themselves
from HIV infection.
"Vaginal rings, commonly used in Europe and the U.S. for
hormone delivery, could be well-suited to deliver HIV prevention
drugs for women in developing countries," said Dr. Zeda
Rosenberg, IPM's Chief Executive Officer. "This study will
provide key information on the safety and acceptability of this
technology for HIV prevention. It is an important step forward
in our efforts to give women options they can use to safeguard
their health."
Since 2001, women in developed countries have successfully used
vaginal rings, such as the NuvaRing, Estring and Femring, for
birth control and hormonal therapy. These rings are appealing
because they are self-administered, discreet and provide protection
for a month or more. The vaginal ring being tested in IPM 015
is an ARV-based microbicide -- a class of vaginal products currently
being developed to prevent HIV infection in women. ARVs have
revolutionized HIV treatment and have already been proven to
reduce mother-to-child transmission of HIV. They are now being
tested for their ability to prevent HIV infection.
The vaginal ring used in IPM 015 is made of flexible silicone,
is durable and would be easy to distribute -- making it well
suited for use in developing countries. Each ring slowly releases
25 mg of the ARV drug dapivirine over the course of 28 days,
potentially providing sustained protection against HIV. The
ring is manufactured by IPM, which has a royalty-free license
for dapivirine from Tibotec Pharmaceuticals, a division of Johnson
& Johnson.
"Biology and gender inequality continue to place women
at greater risk of disease and death, particularly in developing
countries," said Elizabeth Mataka, the UN Secretary-General's
Special Envoy for AIDS in Africa. "All too often, women
are not in a position to control their sexual health or protect
themselves from HIV infection. By empowering women with new
tools to protect their health, this ring technology could bring
hope where there was none before."
IPM 015 is a Phase I/II expanded safety trial that will compare
the dapivirine ring with a placebo ring containing no active
drug among 280 volunteers across Africa. Women in South Africa
have begun volunteering for the trial, and it is hoped that
other African nations will start the same study shortly. The
women volunteers will be randomly assigned to use either the
dapivirine or the placebo ring, which will be replaced once
monthly for a three-month period.
The vaginal ring containing dapivirine has already been shown
to be safe as tested in four prior IPM clinical trials among
women in Europe, with another trial ongoing. If IPM 015 further
confirms the safety and acceptability of the product among women
in Africa, a Phase III program to test the ability of dapivirine
rings to prevent HIV infection is scheduled to begin in Africa
in 2011, with results due in 2015.
"The roll-out of treatment in the past few years has saved
millions of lives, but the AIDS epidemic continues to spread,
with women particularly vulnerable," said Michel Sidibé,
the Executive Director of UNAIDS. "Preventing HIV transmission
is essential if we are to protect the health and safety of future
generations. If successful, innovations like microbicides could
have an extraordinary impact."
Every day more than 3,000 women worldwide become infected with
HIV. And HIV/AIDS is the leading cause of death for women aged
15-49 years in Africa. Despite this challenge, women lack a
discreet method to prevent infection. Current prevention options
may be impractical for women who lack the power to ensure that
their male partners use condoms or remain faithful, and for
those who are married, want to have children or are at risk
of violence.
The initiation of IPM 015 was announced at the Women Deliver
conference in Washington, D.C., the largest conference focused
on maternal health in more than a decade.
"Women and girls must be given the tools to protect themselves
from HIV infection," said Jill Sheffield, President of
Women Deliver. "The contraceptive ring has been a formidable
tool for women seeking more control over their reproductive
health, and it is wonderful to see HIV researchers adapt this
technology to tackle the single biggest killer of young women.
The simple fact is that we will never be able to fully ensure
the health of women and girls globally without halting the spread
of HIV and AIDS."
A
video of IPM's recent press conference is available online.
About IPM:
IPM is a nonprofit product development partnership established
in 2002 to prevent HIV transmission by supporting the development
and availability of safe and effective vaginal microbicides
and other HIV prevention methods in developing countries where
women are at greatest risk for infection. IPM has offices in
the United States, South Africa and Belgium. Please visit www.IPMglobal.org.
